An observational study in Coronary Disease, Coronary Artery Disease and Coronary Restenosis, sponsored by Luzerner Kantonsspital. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by Luzerner Kantonsspital · Observational
The purpose of the SIROOP Registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone PCI and are treated with either currently available sirolimus or paclitaxel coated DCBs (see Table 1), irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. Outcomes will be compared in different clinical subgroups. The impact of current DCBs in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.
Objectives in detail:
To evaluate procedural success, efficacy, performance and clinical outcomes among various patient cohorts, who undergo PCI using currently available DCBs:
1,520 studies on the registry are indexed under Coronary Disease; 167 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 916 across 478 observational studies indexed under Coronary Disease.
Browse Coronary Disease studies →Luzerner Kantonsspital is the lead sponsor of 62 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This registry will recruit consecutive patients treated with either DCB alone or a hybrid strategy (metallic stent plus DCB). Ideally any patient treated with a DCB will be included in the present registry, either presenting with a de-novo coronary lesion (either elective or urgent procedure), with a ST or ISR.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The project ́s main goal is to collect baseline, clinical and procedural data as well as to assess angiographic and clinical outcomes of CAD patients treated with contemporary DCBs.
Device: Sirolimus Eluting Balloon
PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon
Also known as: Paclitaxel Eluting Balloon
Rate of target lesion failure (TLF) and target lesion revascularization (TLR)
Time frame: at 1 year
Rate of combination of major adverse cardiac and cerebrovascular events (MACCE) (including new MI, TLR or cardiovascular death)
Time frame: at 180 days, 1, 2 and 5 years
Rate of MACE
Time frame: at 180 days, 1, 2 and 5 years
Rate of new MI (NSTEMI / STEMI)
Time frame: at 180 days, 1, 2 and 5 years
Rate of TIA or stroke
Time frame: at 180 days, 1, 2 and 5 years
Rate of acute vessel closure
Time frame: at 180 days, 1, 2 and 5 years
Rate of stent thrombosis or ISR
Time frame: at 180 days, 1, 2 and 5 years
Rate of target vessel revascularization (TVR)
Time frame: at 180 days, 1, 2 and 5 years
Rate of target lesion revascularization (TLR)
Time frame: at 180 days, 1, 2 and 5 years
Rate of target lesion failure (TLF)
Time frame: at 180 days, 1, 2 and 5 years
Rate of ischemia driven TLR
Time frame: at 180 days, 1, 2 and 5 years
Rate of all-cause death
Time frame: at 180 days, 1, 2 and 5 years
Rate of cardiac death
Time frame: at 180 days, 1, 2 and 5 years
Rate of all myocardial infarction and TV-MI
Time frame: at 180 days, 1, 2 and 5 years
Rate of rehospitalization for recurrent angina
Time frame: at 180 days, 1, 2 and 5 years
Rate of hospitalization for HF
Time frame: at 180 days, 1, 2 and 5 years
Rate of rehospitalization for HF, resuscitated cardiac arrest or implantable cardioverter- defibrillator (ICD) implantation
Time frame: at 180 days, 1, 2 and 5 years
Rate of bleeding events (access site or non-access site related) according to the BARC classification
Time frame: at 180 days, 1, 2 and 5 years
Rate of vascular complications (according to VARC criteria)
Time frame: at 180 days, 1, 2 and 5 years
Rate of cardiogenic shock
Time frame: at 180 days, 1, 2 and 5 years
Rate of acute renal failure/ contrast-induced nephropathy (CIN)
Time frame: at 180 days, 1, 2 and 5 years
Rate of new ventricular arrhythmias
Time frame: at 180 days, 1, 2 and 5 years
Rate of major adverse limb events (MALE)
Time frame: at 180 days, 1, 2 and 5 years
Rate of new York Heart Association (NYHA) class
Time frame: at 180 days, 1, 2 and 5 years
Rate of angina according to Canadian Cardiovascular Society (CCS) Score
Time frame: at 180 days, 1, 2 and 5 years
Rate of procedural success (final diameter stenosis < 30% without flow-limiting dissections)
Time frame: at 180 days, 1, 2 and 5 years
Rate of periprocedural complications (e.g. coronary perforations, no-reflow)
Time frame: at 180 days, 1, 2 and 5 years
Started Jun 2021 (actual). Primary completion is estimated for Dec 2026, 66 months after the start.
Of 132 non-industry observational studies under Coronary Disease, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 192. This study's planned 66 months is above that.
Counting every sponsor, half of 154 studies reached it within 47 months; a quarter within 21 and three quarters within 123.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Luzerner Kantonsspital